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Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin

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ClinicalTrials.gov Identifier: NCT02310373
Recruitment Status : Terminated (Responsible Party/PI passed away. All subjects enrolled completed study prior to termination.)
First Posted : December 8, 2014
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Cedars-Sinai Medical Center

Brief Summary:
This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.

Condition or disease Intervention/treatment Phase
Nicotine-free Hookah Smoking Other: Nicotine free hookah smoking Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
Study Start Date : November 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Nicotine free hookah (herbal/steam stones) smoking
Healthy habitual Hookah smokers will undergo microneurography, myocardial contrast echocardiogram or venous occlusion plethysmography before and after nicotine free hookah smoking.
Other: Nicotine free hookah smoking
Subjects will smoke waterpipe in a controlled research environment




Primary Outcome Measures :
  1. Change in sympathetic nerve activity [ Time Frame: Change from baseline in sympathetic nerve activity at 1 hr ]
    Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve.


Secondary Outcome Measures :
  1. Change in regional myocardial perfusion [ Time Frame: Change from baseline in regional myocardial perfusion at 1 hr ]
    Myocardial contrast echocardiography will be used to measure regional myocardial perfusion (i.e. capillary blood volume) and coronary flow reserve.


Other Outcome Measures:
  1. Change in leg blood flow [ Time Frame: Change from baseline in leg blood flow at 1 hr ]
    Lower leg blood flow will be measured with standard venous occlusion plethysmography.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 39 years of age
  • Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months
  • Have not smoked cigarettes within the past 12 months

Exclusion Criteria:

  • Exhaled carbon monoxide level greater than 10 ppm* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
  • History of cardiopulmonary disease
  • Use of any prescription medication with exception of oral contraceptive pills
  • History of psychiatric illness
  • History of neurologic disease
  • BMI ≥ 35
  • Evidence of any of the above by physical examination, ECG or echocardiogram
  • Smoked cigarette in the past 12 months
  • History of illicit drug use
  • Pregnant
  • Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310373


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Ronald G Victor Cedars-Sinai Medical Center
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Responsible Party: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02310373    
Other Study ID Numbers: Pro00037529
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Keywords provided by Cedars-Sinai Medical Center:
Nicotine-free hookah
Waterpipe
Smoking
Sympathetic
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action